Whether a study team must report a financial conflict of interest COI) to its local IRB depends on that institution’s policies. If the SMART IRB Standard Operating Procedures are being followed for a study, research teams must first disclose this financial COI, as well as any applicable management plans, to their institution’s Point of Contact (POC), who will then assess whether the COI impacts their decision to cede IRB review.
Note: This article is applicable to non-federal Relying Institutions only. In the case of federal agency study teams, research personnel may be asked to provide an assurance that the agency has completed COI analyses and that the participation of agency research personnel is permissible and consistent with federal law. See the SMART IRB Agreement v2.0 FAQS as well as NIH's Guidance on the Conflict of Interest Policies of the NIH Intramural Research Program for more information.